New products for pharmacists

August 15, 2013

New Rx, indications, generics, and OTC

New Rx

Nearly a year after gaining FDA approval, prescriptions for Qsymia, once-daily phentermine and topiramate extended-release tablets from Vivus, can now be filled at about 8,000 pharmacies nationwide. Qsymia is FDA-approved as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index of 30 kg/m2 or greater (obese), or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related medical condition such as high blood pressure, type 2 diabetes, or high cholesterol. Until recently, the drug was available only through mail-order pharmacies. FDA required extra regulation because Qsymia can cause birth defects if taken by pregnant women. However, FDA has eased the requirements for dispensing Qsymia and now allows certified retail pharmacies to fill the prescriptions. The drug is now available at certified Walgreens, Costco, and Duane Reade pharmacies. (www.qsymia.com)

FDA has approved Orexo’s Zubsolv, a once-daily sublingual tablet CIII, containing both buprenorphine and naloxone for use as maintenance treatment for opioid dependence. According to the manufacturer, it should be used as part of a complete treatment plan that includes counseling and psychosocial support. Compared with other buprenorphine/naloxone treatments, Zubsolv is said to have a higher bioavailability, faster dissolve time, and smaller tablet size with a new menthol taste. The company’s subsidiary Orexo US and partner Publicis Touchpoint Solutions will launch the product in September. (www.orexo.com)

Brisdelle low-dose paroxetine capsules, 7.5 mg/day, from Noven Therapeutics, have received FDA approval for the treatment of moderate to severe menopause-related vasomotor symptoms (VMS) such as hot flashes and night sweats. Prior to this approval, hormone therapy was the only FDA-approved treatment for VMS. Hot flashes associated with menopause occur in up to 75% of women and can persist for up to 5 years, or even longer for some women. Brisdelle is dosed once daily at bedtime. Other medications such as Paxil and Pexeva contain higher doses of paroxetine and are approved for treating conditions such as major depressive disorder, obsessive-compulsive disorder, panic disorder, and generalized anxiety disorder. Brisdelle will be available in U.S. pharmacies in November. (www.brisdelle.com)

In mid-July, FDA approved Gilotrif (afatinib) for patients with metastatic non-small-cell lung cancer whose tumors express specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test. Gilotrif, marketed by Boehringer Ingelheim Pharmaceuticals, is a tyrosine kinase inhibitor that blocks proteins the promote the development of cancerous cells. It can be used for patients whose tumors express the EGFR exon 19 deletions or exon 21 L858 substitution gene mutations. The drug was approved concurrently with the Therascreen EGFR RGQ PCR Kit, a companion diagnostic that helps determine whether a patient’s lung-cancer cells express the EGFR mutations. (http://us.boehringer-ingelheim.com)

New indications

FDA has expanded the approved use of the antibiotic Vibativ (telavancin) to treat patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by Staphylococcus aureus. Vibative can be used for the treatment of HABP/VABP only when alternative treatments are not suitable. Vibative was approved in 2009 to treat complicated skin and skin-structure infections. The product is marketed by Theravance Inc. (www.vibativ.com).

FDA has approved two new indications for Latuda (lurasidone HCl), from Sunovion and Dainippon Sumitoma Pharma. Latuda can be used a monotherapy and adjunctive therapy with either lithium or valproate to treat adult patients with major depressive episodes associated with bipolar I disorder. This is the first atypical antipsychotic to receive FDA approval as both monotherapy and adjunctive therapy with lithium or valproate for the treatment of bipolar depression. (http://www.latuda.com)

FDA has approved Astellas Pharma’s Astagraf XL (tacrolimus extended-release capsules) for the prophylaxis of organ rejection in patients receiving a kidney transplant with mycophenolate mofetil and corticosteroids, with or without basiliximab induction. This is the first once-daily oral tacrolimus formulation available in the United States for kidney transplant recipients. Astellas’ Prograf (tacrolimus) is available in the United States in the form of IV infusion to prevent organ rejection in patients who have had a kidney, liver or heart transplant. (http://www.us.astellas.com)

New generics

In mid-July, FDA approved Lupin’s ANDA for metformin hydrochloride extended-release tablets in the 500-mg and 1,000-mg strengths. The generic drug is equivalent to Santarus’ Glumetza. Lupin received 180-day exclusivity for these doses. (www.lupinpharmaceuticals.com)

Also in mid- July, FDA approved Actavis’ oxymorphone hydrochloride extended-release tablets in the 5-mg, 10-mg, 20-mg, 30-mg, and 40-mg strengths, the generic version of Endo Health Solutions’ Opana ER. The product is based on a non-crush-resistant version that was withdrawn from the market last year. Actavis already markets the 7.5-mg and 15-mg versions. An FDA rule that was finalized earlier in the year allows for generic versions of the earlier formulation of Opana ER, though Endo produces only the crush-resistant formulation. Actavis also received FDA approval for its generic version of Lamictal orally disintegrating tablets by GlaxoSmithKline. The company plans to launch lamotrigine orally disintegrating tablets immediately. They will be available in the following doses: 25 mg, 50 mg, 100 mg, and 200 mg. (http://ir.actavis.com)

At the end of June, Dr. Reddy’s launched its lamotrigine extended-release tablets, a generic therapeutic equivalent to Lamictal XR, following FDA approval of its ANDA for lamotrigine XR tablets. The tablets are available in the following doses: 25 mg, 50 mg, 100 mg, 200 mg, and 300 mg. (www.drreddys.com)

In mid-July, Par Pharmaceuticals received FDA approval for its ANDA for fenofibric aciddelayed-release (DR) capsules in 45 mg and 135 mg,  generic for AbbVie’s Trilipix. (www.parpharm.com/generics)

New OTC

In June, FDA approved the emergency contraceptive Plan B One-Step (levonorgestrel, Teva Women’s Health) tablet 1.5 mg for over-the-counter sale to all consumers in the United States. It is the first one-tablet emergency contraceptive to be available in store aisles without age or point-of-sale restrictions. (www.planbonestep.com)

Nordic Naturals’ Professional Division has introduced Pro EPA with Concentrated GLA (gamma-linolenic acid), a product that offers a high concentration of omega-3 eicosapentaenoic acid (EPA) and omega-6 gamma-linolenic acid (GLA), as well as omega-3 docosahexaenoic acid (DHA) for comprehensive essential fatty acid support. According to the company’s chief medical officer, EPA, DHA, and GLA are essential for optimal health. The EPA and DHA in the product are derived from wild-caught sardines and anchovies. The GLA is from borage seed. (www.nordicnaturals.com/professionals.php)